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Xylitol Wipes to Prevent Infections in Pediatric Stem Cell Transplant

This study is testing whether xylitol wipes can help prevent serious bloodstream infections (BSIs) in children and young adults (ages 4 months to 25 years) who are having an allogeneic stem cell transplant (SCT). These infections, caused by germs from the mouth, are a big problem for patients after transplant. Currently, there's no good way to prevent them. You would receive either grape-flavored xylitol wipes or grape-flavored placebo (inactive) wipes to use in your mouth twice a day, in addition to your usual care. Researchers will check if xylitol reduces BSIs from oral organisms after 33 days. This study is taking place at Cincinnati Children's Hospital Medical Center, Boston Children's Hospital, and Children's Hospital of Colorado. The current status of the study is unclear.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to receive either xylitol or a placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 256 participants.
What's involved
You would use either grape-flavored xylitol wipes or grape-flavored saline wipes in your mouth twice daily. This is in addition to your current standard medical care.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study, bacteremia from an oral organism, is measured at 33 days.

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NCT05579639

Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

Active, Not Recruiting
PHASE2Ages 4–25InterventionalPrevention
Children's Hospital Medical Center, Cincinnati
~256 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:XylitolPlacebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bacteremia from an oral organism
Measured over 33 days

Conditions

Allogeneic Stem Cell Transplantation

Explore related trials

Allogeneic Stem Cell Transplantation

Where it's being run

3 sites across 3 states
Colorado1
Massachusetts1
Ohio1

Study leadership

  • Christopher Dandoy, MD, MSc · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provide signed and dated informed consent and assent (when applicable) form
Willing to comply with all study procedures and be available for the duration of the study
Admitted and planning to undergo an allogeneic stem cell transplant (SCT) at Cincinnati Children's Hospital Medical Center (CCHMC), Boston Children's Hospital, or Children's Hospital of Colorado (Denver).
Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
Have a minimum of one tooth
Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period

Exclusion

Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record
Cranial boost in patients receiving total body irradiation
Known history of allergy to xylitol
Known history of allergy to grapes or grape flavoring
Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)

What this trial measures

  • Bacteremia from an oral organism33 days

    Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo